Safety, immunogenicity and clinical response of sig-HELP-E6SH/E7SH-kdel, injected in the epidermis by DNA tattoo, in HPV16-positive vulvar intraepithelial neoplasia: a phase I/II study - HPV16 E6-E7

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•* Age above 18 years
•* Willing and able to undergo the planned study procedures
•* Written informed consent
•* Histologically proven visible uVIN lesion (histology *3 months prior to enrolment and at least 6 weeks after last treatment)
•* HPV16-positive VIN lesion (to be determined on archival tumour tissue (*10 years old); if not available a new biopsy will be required)
•* No indication of an active infectious disease: HIV, HCV and HBV negative
•* No history of autoimmune disease or systematic undercurrent disease which might affect immunocompetence
•* Adequate bone marrow (WBC > 3.0/nL, platelets > 100/nL), renal function (creatinine clearance > 40 mL/min), and liver function (bilirubin < 1.5 x ULN, normal blood coagulation)

•* Prior treatment with anti-HPV agents
•* Participation in a study with another investigational drug within 30 days prior to enrolment in this study
•* Severe cardiac, respiratory, or metabolic disease
•* Use of systemic steroids or other immunosuppressive drugs
•* Use of oral anticoagulant drugs (except ascal)
•* Severe infections requiring antibiotics
•* Any treatment for the uVIN lesion within 6 weeks prior to the enrolment (including imiquimod)
•* Lactation or pregnancy (if applicable)
•* Not willing to take adequate contraceptive measures (if applicable)

发起方

Antoni van Leeuwenhoek Ziekenhuis